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Focus on Regulation

EMA’s pre-authorisation procedural advice for the centralised procedure updated

The European Medicines Agency (“EMA”) has published an updated version of the guidance document on pre-authorisation for users of the centralised procedure. The update relates to a new question concerning the preparation of the dossier.


The EMA’s guidance document helps applicants for marketing authorisations in the European Union (“EU”) to prepare correct and timely pre-authorisation submissions within the centralised procedure.

The guide addresses a number of questions which applicants through the centralised procedure may have concerning pre-authorisation applications.

The guidance document is structured into Question & Answers. It is revised regularly to keep pace with new developments and to reflect the implementation of the new EU legislation. The document should be read in conjunction with The rules governing medicinal products in the European Union, Volume 2A, Notice to Applicants.

The new question

Updated topics in the guidance document are marked as “NEW” or “Rev.” with the relevant date of publication.

The recent 6 February 2018 version includes the following new question in Section 3 on the preparation of the dossier:

“What is a multipack presentation and which information should include in the product information for a multipack presentation?”

The answer clarifies that the term “multipack” can be included in the dossier solely when it concerns a presentation composed of several single authorised packs of the same strength. The guidance document provides related detailed advice concerning preparation of the multipack outer carton and inner boxes.